A Study of TACE Combined With Atezolizumab Plus Bevacizumab or TACE Alone in Patients With Untreated Heaptocellular Carcionma
NCT ID: NCT04712643
Last Updated: 2025-10-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE3
342 participants
INTERVENTIONAL
2021-03-12
2029-02-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Arm A: atezolizumab + bevacizumab + TACE
Participants will receive atezolizumab plus bevacizumab on Day 1 of a 21-Day cycle, after every on-demand transarterial chemoembolization procedure.
Atezolizumab
Atezolizumab will be administered by IV infusion at a fixed dose of 1200 mg on Day 1 of each 21-day cycle until participant experience loss of clinical benefit as evaluated by the investigator or unacceptable toxicity or withdrawal of informed consent.
Becavizumab
Bevacizumab will be administered by IV infusion at a fixed dose of 15 mg/kg on Day 1 of each 21-day Cycle.
Transarterial chemoembolization (TACE)
TACE will be performed by clinical demand.
Arm B: TACE alone
Participants will receive on-demand transarterial chemoembolization.
Transarterial chemoembolization (TACE)
TACE will be performed by clinical demand.
Interventions
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Atezolizumab
Atezolizumab will be administered by IV infusion at a fixed dose of 1200 mg on Day 1 of each 21-day cycle until participant experience loss of clinical benefit as evaluated by the investigator or unacceptable toxicity or withdrawal of informed consent.
Becavizumab
Bevacizumab will be administered by IV infusion at a fixed dose of 15 mg/kg on Day 1 of each 21-day Cycle.
Transarterial chemoembolization (TACE)
TACE will be performed by clinical demand.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Eligible for TACE treatment
* No prior systemic therapy for HCC, especially immunotherapy
* No prior locoregional therapy to the target lesion(s)
* At least one measurable untreated lesion
* ECOG Performance Status of 0-1
* Child-Pugh class A
Exclusion Criteria
* Evidence of extrahepatic spread (EHS)
* Being a candidate for curative treatments
* Any condition representing a contraindication to TACE as determined by the investigators
* Active or history of autoimmune disease or immune deficiency
* Untreated or incompletely treated esophageal and/or gastric varices with bleeding or high risk for bleeding
* A prior bleeding event due to esophageal and/or gastric varices within 6 months prior to initiation of study treatment
* Evidence of bleeding diathesis or significant coagulopathy
18 Years
ALL
No
Sponsors
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Hoffmann-La Roche
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
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Anhui Provincial Hospital
Anhui, , China
Peking University First Hospital
Beijing, , China
Peking University People's Hospital
Beijing, , China
Beijing You An Hospital
Beijing, , China
Beijing Tsinghua Changgung Hospital
Beijing, , China
Hunan Cancer Hospital
Changsha, , China
West China Hospital, Sichuan University
Chengdu, , China
The First Affiliated Hospital, Chongqing Medical University
Chongqing, , China
Southwest Hospital , Third Military Medical University
Chongqing, , China
The 900th Hospital of PLA joint service support force
Fuzhou, , China
The First Affiliated Hospital Of Fujian Medical University
Fuzhou, , China
Fujian Cancer Hospital
Fuzhou, , China
Mengchao Hepatobiliary Hospital Of Fujian Medical University
Fuzhou, , China
Sun Yet-sen University Cancer Center
Guangzhou, , China
Nanfang Hospital, Southern Medical University
Guangzhou, , China
Zhejiang Cancer Hospital
Hangzhou, , China
Harbin Medical University Cancer Hospital
Harbin, , China
Jiangsu Cancer Hospital
Nanjing, , China
Jiangsu Province Hospital (the First Affiliated Hospital With Nanjing Medical University)
Nanjing, , China
Guangxi Cancer Hospital of Guangxi Medical University
Nanning, , China
The First Affiliate Hospital of Guangxi Medical University
Nanning, , China
Fudan University Shanghai Cancer Center
Shanghai, , China
Renji Hospital Shanghai Jiaotong University School of Medicine
Shanghai, , China
Zhongshan Hospital Fudan Unvierstiy
Shanghai, , China
Shengjing Hospital of China Medical University
Shenyang, , China
Tianjin Cancer Hospital
Tianjin, , China
The First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, , China
Xi'an Inernational Medical Center Hospital
Xi'an, , China
Henan Cancer Hospital
Zhengzhou, , China
Zhuhai People's Hospital
Zhuhai, , China
Aichi Cancer Center
Aichi, , Japan
Chiba University Hospital
Chiba, , Japan
Kurume University Hospital
Fukuoka, , Japan
Hiroshima University Hospital
Hiroshima, , Japan
Yokohama City University Medical Center
Kanagawa, , Japan
Kanagawa Cancer Center
Kanagawa, , Japan
Kitasato University Hospital
Kanagawa, , Japan
The University of Osaka Hospital
Osaka, , Japan
Kindai University Hospital
Osaka, , Japan
Toranomon Hospital
Tokyo, , Japan
Countries
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Other Identifiers
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ML42612
Identifier Type: -
Identifier Source: org_study_id
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